BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 5MM REVERSE CURETT

    MDR report key: 2763304 · Received September 27, 2012

    Report

    Report Number
    0001825034-2012-01755
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 29, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND FRACTURE DUE TO BENDING OVERLOAD. THERE ARE NO VISIBLE DEFECTS THAT APPEAR TO BE CAUSED BY BIOMET. USER ERROR IS SUSPECTED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01755-1 / 01756-1).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "INTRAOPERATIVE FRACTURE OR BREAKAGE OF INSTRUMENTS HAS BEEN REPORTED." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01755 / 01756).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PROCEDURE ON (B)(6) 2012. DURING PROCEDURE SURGEON ATTEMPTED TO DEBULKE THE FEMUR CANAL WITH THE REVERSE CURRETTE FOUR TIMES WHEN TIP FRACTURED. SURGEON THEN ATTEMPTED THREE TIMES WITH A 9.5 DISK DRILL BEFORE THE TIP FRACTURED. BOTH TIPS REMAIN IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA DRIVE 5MM REVERSE CURETT DEVICE JXE BIOMET ORTHOPEDICS N/A 670910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S